Air particle counter equipment qualification (IQ and OQ)


is it acceptable if IQ/OQ is performed by the third party without been witnessed by the user?

(Ankur Choudhary) #2

IQ/OQ can be performed by the third party but in the presence of the user.

(Simon Gooden) #3

In my experience you can purchase a written PQ from the manufacturer. Combined with other appropriate documents, it will serve as a validation package for the equipment which is needed to validate the EM program for the facility.